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Due to time constraints, the study was halted prematurely
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RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in destructive arthritis if not treated rapidly. Inspite of various advances in field of early diagnosis and treatment of RA, there is still a need for better understanding of the efficacy and safety of various combinations of conventional DMARDS, and to rank them in order accordingly, so as to give a clearer vision for further management of RA once MTX monotherapy fails, so as to achieve remission as soon as possible. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education & Research). patients who fail methotrexate monotherapy will be randomised to 2 treatment arms - either a combination of Sulfasalazine (SSZ), Hydroxychloroquine (HCQ) and Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine (HCQ) and Methotrexate (MTX)
Patients aged ≥18 years, fulfilling the 2010 ACR EULAR criteria for RA (symptom duration less than two years) , having more than 4 joints involved & having moderate to severe disease activity (DAS28≥3.2) will be invited to participate. After providing written informed consent, eligible patients will be first started on MTX monotherapy & only patients who have persistant moderate disease activity (DAS28 ESR > 3.2) will be randomized into two groups. Block randomization will be done to generate random allocation sequence
Group 1 - will receive MTX+LEF+HCQ Group 2- will receive MTX+SSZ+HCQ
DMARD dosages used are: MTX 25 mg/week orally (dosage after 6 weeks),SSZ 2g/d (after 4 weeks) LEF 20 mg/day (dosage after 2 weeks) and HCQ 200 mg/day. Glucocorticoids will be given in an oral tapering scheme. All patients will be prescribed folic acid (10 mg/week) during MTX prescription.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1- MTX+LEF+HCQ | Active Comparator | Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. |
|
| group 2- MTX+SSZ+HCQ | Active Comparator | Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | EULAR response criteria for Rheumatoid arthritis includes- estimation of DAS 28 ESR, that includes-
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity as Per Ultrasound-7 (US-7) Score | Ultrasound 7 score (US-7) Calculates ultrasound score in 7 joints using greyscale and power doppler to evaluate for disease activity (synovitis, tenosynovitis) and damage (erosions) Score minimum value= 0 Maximum value = 108 Higher score indicates worse disease | 12 weeks |
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Inclusion Criteria:
Age >18 years satisfying ACR-EULAR criteria for RA
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vir S Negi, DM | Jawaharlal Institute of Postgraduate Medical Education & Research | Principal Investigator |
| Pooja Belani, MD | Jawaharlal Institute of Postgraduate Medical Education & Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Immunology , Jawaharlal Institute of Post graduate Medical Educationa and Research | Puducherry | 605006 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34586472 | Derived | Belani PJ, Kavadichanda CG, Negi VS. Comparison between leflunomide and sulfasalazine based triple therapy in methotrexate refractory rheumatoid arthritis: an open-label, non-inferiority randomized controlled trial. Rheumatol Int. 2022 May;42(5):771-782. doi: 10.1007/s00296-021-04994-1. Epub 2021 Sep 29. |
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patients were enrolled from OPD (outdoor patient department) of Rheumatology clinic of JIPMER , from September 2016 to March 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1- MTX+LEF+HCQ | Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 2, 2016 |
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| Leflunomide | Drug | Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease |
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| Hydroxychloroquine | Drug | Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. |
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| Prednisolone | Drug | Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) |
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| Folic Acid | Drug | Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. |
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| Sulfasalazine | Drug | 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF) |
|
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| Number of Participants With Adverse Drug Reactions |
Infections, transaminitis, nausea, vomiting, derranged renal function tests etc |
| 24 weeks |
| Indian Health Assessment Questionnaire (iHAQ) | Indian version of Health assessment Questionnaire (iHAQ) Comprises of 12 questions relating to functional activity iHAQ score ranges from 0 to 3 (minimum 0, maximum 3) Higher scores indicate more disability | 12 weeks |
| FG001 | Group 2- MTX+SSZ+HCQ | Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1- MTX+LEF+HCQ | Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. |
| BG001 | Group 2- MTX+SSZ+HCQ | Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All patients above 18 years age, satisfying inclusion criteria were included | Median | Inter-Quartile Range | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Disease duration (months) | Median | Inter-Quartile Range | months |
| |||||||||||||||
| Rheumatoid factor positivity | Rheumatoid factor was evaluated by the Nephelometry method. A value of more than equal to 20IU/ml was considered positive | Count of Participants | Participants | No |
| ||||||||||||||
| Anti- cyclic citrullinated peptide antibody | Count of Participants | Participants | No |
| |||||||||||||||
| DAS28ESR | Full form : Disease activity score 28 joint ESR Measure of disease activity. Calculated from tender joint count, swollen joint count, patient VAS for global health and ESR. score ranges from 0 to 9.3 Higher score indicates higher disease activity | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| Tender joint count (TJ28) | Includes the number of tender joints by palpation (includes all joints of both hands except distal interphalangeal joints, both elbows, both shoulders and both knees) Ranges from 0 to 28. | Median | Inter-Quartile Range | tender joints |
| ||||||||||||||
| Swollen joint count (SJ28) | Includes the number of joints that are swollen as per the examing physician. includes all joints of both hands (except distal interphalangeal joints), both wrists, elbows , shoulders and knees. Ranges from 0 to 28 | Median | Inter-Quartile Range | swollen joints |
| ||||||||||||||
| Baseline ESR (mm at the end of 1 hour) | ESR was measured using Westergren tube. The value ranges from 0 to 200 millimeters (mm). | Median | Inter-Quartile Range | millimeter (mm) |
| ||||||||||||||
| Early morning stiffness (EMS) (minutes) | Median | Inter-Quartile Range | minutes |
| |||||||||||||||
| patient VAS global health | Value ranges from 0 to 100. Higher value indicates worse disease for patient overall health | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| Indian Health assessment questionnaire | Value ranges from 0 to 3 (calculated from 12 questions) where higher score indicates worse disease | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| Ultrasound7 score (US7 score) | Calculated from ultrasound assessment of 7 joints. Calcutes for disease activity (synovitis and effusion) and damage (erosions) using grey scale and power doppler Ranges from 0 to 108 Higher score indicates higher disease activity | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | EULAR response criteria for Rheumatoid arthritis includes- estimation of DAS 28 ESR, that includes-
| Analysis was done by intention to treat | Posted | Number | participants | 12 weeks |
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| Secondary | Disease Activity as Per Ultrasound-7 (US-7) Score | Ultrasound 7 score (US-7) Calculates ultrasound score in 7 joints using greyscale and power doppler to evaluate for disease activity (synovitis, tenosynovitis) and damage (erosions) Score minimum value= 0 Maximum value = 108 Higher score indicates worse disease | intention to treat analysis | Posted | Median | Inter-Quartile Range | units on a scale | 12 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Drug Reactions | Infections, transaminitis, nausea, vomiting, derranged renal function tests etc | Posted | Count of Participants | Participants | 24 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Indian Health Assessment Questionnaire (iHAQ) | Indian version of Health assessment Questionnaire (iHAQ) Comprises of 12 questions relating to functional activity iHAQ score ranges from 0 to 3 (minimum 0, maximum 3) Higher scores indicate more disability | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks |
|
24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1- MTX+LEF+HCQ | Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. | 0 | 68 | 0 | 68 | 15 | 68 |
| EG001 | Group 2- MTX+SSZ+HCQ | Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF) | 0 | 68 | 0 | 68 | 21 | 68 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal adverse events | Gastrointestinal disorders | Systematic Assessment | Includes nausea, vomiting, abdominal pain and diarrhea |
| |
| infections | Infections and infestations | Systematic Assessment | Any infection during study period was noted |
| |
| hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Hairfall | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Raised liver enzymes | Hepatobiliary disorders | Systematic Assessment | Liver enzymes > 2 times upper limit normal |
| |
| Switch to parenteral Methotrexate | Product Issues | Systematic Assessment | Patients intolerant to Methotrexate were switched to parenteral form as per study protocol |
|
Early termination resulted in enrollment of 136 patients instead of 140 patients.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pooja Belani | JIPMER | 8940482248 | drpoojabelani@gmail.com |
| Feb 23, 2021 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D000077339 | Leflunomide |
| D006886 | Hydroxychloroquine |
| D011239 | Prednisolone |
| D013256 | Steroids |
| D005938 | Glucocorticoids |
| D005492 | Folic Acid |
| D012460 | Sulfasalazine |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| OG001 | Group 2- MTX+SSZ+HCQ | Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF) |
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Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy. Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine. Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week. Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF) |
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